Early engagement and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful registration. In addition, early discussion with HTA bodies and other stakeholders can be critical towards early patient access and commercial success in Europe. There is growing interest in the EMA/EUnetHTA Parallel Consultation Process. In this webinar, Florence Bine-Scheck, Senior Medical Director and Carole Jones, Director of Market Access at VCLS will share their insights through some case studies on the importance of seeking parallel HTA-EMA advice and how to be well prepared for the meeting to ensure both successful  registration and commercial success.

Key learning objectives:

  • Understand the difference between the European Medicines Agency (EMA) Scientific Advice and the EMA/EUnetHTA Parallel Consultation procedure
  • Weigh the pros and cons when considering the choice of an EMA/EUnetHTA Parallel Consultation procedure
  • Steps to a well-prepared meeting: how to best plan for an EMA/EUnetHTA Parallel Consultation procedure and how to ask the right questions to obtain relevant information out of the process

 

Keywords:

European Medicines Agency (EMA), Healthcare Technology Assessment (HTA) bodies, Parallel Scientific Advice, EMA/EUnetHTA Parallel Consultation, Market Access

Florence_Bine-Scheck

Florence Bine-Scheck, Senior Medical Director

As Head of the Clinical Development group, Florence provides advice on projects involving mainly the design of clinical development plans and clinical trial protocols, Scientific Advice Procedures, Risk Management Plans, Paediatric Investigation Plans and Compassionate Use Programs.

Carole Jones, B.Sc., M.B.A, Director, Market Access

Carole Jones, Head Market Access

Carole joined VCLS in January 2017 to support the development of the Market Access service. Carole’s responsibilities will span Health Economics & Outcomes Research (HEOR), Health Technology Assessment (HTA) and value communications support.

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